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48 November 2017 Tablets & Capsules Debossing. Tablet identification formed as a groove or indentation in the tablet's surface. Deduster. A piece of equipment that removes flashing and dust from solid dosage forms. It is often combined with a metal detector and installed at the outlet of a tablet press or capsule filler. Delivery platform. A series or collection of proprietary methods, processes, or materials that facilitates the for- mulation of drug products and dietary supplements. Dented end. A dimple-like imperfection in the dome area of a capsule cap or body. Desiccant. A highly hygroscopic substance used to absorb moisture in bottles, vials, blisters, and other packaging. Dial pack. A package that must be turned at a specific interval to remove a dose. Commonly used for oral con- traceptives. Die. A circular machine tool with a central cavity in which powders or granular solids are compacted into tablet form between the upper and lower punches of a tablet press. Dietary ingredient. A substance or mixture of substances used in the manufacture of dietary supplements that may or may not address a dietary deficiency. Substances may be extracts or concentrates and include vitamins, miner- als, amino acids, and herbs, among others. Dietary supplement. A solid dosage form that contains a substance or mixture of substances that may or may not address a dietary deficiency. Also known as a nutraceutical. Direct-heat drying. A method by which hot gas directly contacts the wet material, causes evaporation, and carries off the vapor. Examples include fluidized beds, pneu- matic conveyors, and rotary or spray dryers. Disintegration. The breakup of a tablet into fine parti- cles—usually less than 2 millimeters in diameter—in water, simulated gastric fluid, or simulated intestinal fluid at body temperature. Dissolution test. A process by which a known amount of API in a dosage form dissolves in unit time under stan- dardized conditions of liquid-solid interface, tempera- ture, and media composition. In cases where an in vitro- in vivo correlation is established, it may measure bioequivalence. Dosage form. The physical form in which a drug prod- uct or dietary supplement is produced and dispensed, such as a tablet or a capsule. Dosage strength. The amount of API present in each dosage form, usually measured in milligrams. Dose. The prescribed amount of medication to be taken. Draft guidance. Potential guidelines published by the FDA for public comment that represent its current think- ing on an industry topic. Final guidelines may be issued by the FDA after it takes the public's comments into consideration. Dry granulation. The process of densifying powders to form granules. It is accomplished by making compacts using roller compaction or a tablet press and then milling them to produce granules of the appropriate size. E Edge chipping. The loss of particles from the juncture of the tablet band and cups during coating or packaging. Elasticity. The extent to which a material will deform and still be able to return to its original shape—an unde- sired material property in tablet ingredients. Embossing. Tablet identification that protrudes above the tablet's surface or punch cup. Encapsulation. The process of enclosing powders, small granules, pastes, semi-solids, or liquids in a protective membrane or capsule. Excipient. An inactive ingredient added to an API during product manufacturing. They are often classed as dilu- ents, binders, flow aids, disintegrants, colorants, or lubri- cants and can act to improve bioavailability and stability, control drug release, add flavor, or mask off-tastes. F Fatigue analysis. A computerized method for determining tool life based on a variety of compacting force conditions. Feeder. A device located beneath a tablet press hopper that directs material into the dies, known as a powder feeder, mechanical feeder, induced-die feeder, or feed frame. Also a device that meters bulk material according to gravity, mass, or volume. Finite element analysis (FEA). A computer-based method of determining stresses and deformations in tablet tools of complex shapes. The technique identifies the weak areas on a punch cup before tablets are produced and enables the designer to make the tools stronger. Flashing. Small extrusions that appear around the tablet's periphery where the band meets the cups. It usually flakes off during handling, dedusting, or coating. Flowability. A measure or characterization of how well powders, granules, and other bulk solids flow. Fluid-bed dryer. A device that dries powder using mechan- ical force and/or airflow to elevate and aerate it, increasing interstitial particle spacing and driving off moisture. Fluid-bed granulation. The process of spraying solution onto aerated powders to form granules. Fluidization. The process of suspending powders or other materials via mechanical force and/or airflow, usu- ally in drying, granulating, or coating operations. The term derives from the fluid-like behavior of the sus- pended powders. Foil. Thin-gauge aluminum, usually 20 to 25 microns thick, that can be used as blister material, push-through lidstock, or backing when combined with film or paper. It is available with a hard or soft temper and can be printed on two sides and in multiple colors.